UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035536 |
|---|---|
| Receipt number | R000022621 |
| Scientific Title | Pilot study to explore additional indication of therapeutic hypothermia for neonates |
| Date of disclosure of the study information | 2019/01/14 |
| Last modified on | 2019/01/14 19:13:13 |
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Basic information
Public title
Pilot study to explore additional indication of therapeutic hypothermia for neonates
Acronym
Additional indication of hypothermia for neonates
Scientific Title
Pilot study to explore additional indication of therapeutic hypothermia for neonates
Scientific Title:Acronym
Additional indication of hypothermia for neonates
Region
| Japan |
Condition
Condition
Neonatal encephalopathy
Classification by specialty
| Neurology | Obstetrics and Gynecology | Pediatrics |
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety of moderate systemic hypothermia for 72 hours in neonates who are either slightly (i) less matured (33-35 weeks), (ii) less severely asphyxiated, (iii) mildly encephalopathic, or (iv) older (6-12 hours) than those cooled in previous phase-III trials.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Death or severe adverse events until hospital discharge
Key secondary outcomes
Days on mechanical ventilation
Age at hospital discharge
Requirement for tube-feeding at discharge
Death or moderate disability (Time Frame: Birth to 18-22 months corrected age)
Brain MRI findings (Time Frame: 5-14 days)
Base
Study type
Interventional
Study design
Basic design
expanded access
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Other |
Interventions/Control_1
Induced whole-body cooling with a target core body temoerature of 33.5C for 72 hours
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 1 | days-old | <= |
Age-upper limit
| 1 | days-old | >= |
Gender
Male and Female
Key inclusion criteria
Neonates are first assessed using the standard criteria for therapeutic hypothermia* (Shankaran et al. NEJM 2005).
1. Neonates born at 36 weeks gestation or greater, and body weight >1799g
2. Postnatal age < 6 hours after birth
3. At least one of the following criteria:
- Apgar score 0-5 at 10 minutes
- Cord or first postnatal blood pH less than 7.0
- Cord or first postnatal blood Base deficit greater than 16 mEq/L
- Need for continued resuscitation at least 10 minutes
4. Abnormal neurological exam suggesting the presence of moderate or severe encephalopathy
Neonates who meet 3 of 4 criteria are assessed for eligibility using the following entry criteria.
Category 1: Neonates < 36 weeks gestation but > 33 0/7 weeks, and/or body weight between 1500g and 1799g.
Category 2: Neonates between 6 and 12 hours of birth when cooling is initiated.
Category 3: At least one of the following criteria:
- Apgar 0-5 at 5 minutes
- pH less than 7.1
- Base deficit greater than 10 mEq/L
Category 4: Abnormal neurological exam suggesting the presence of mild encephalopathy
Key exclusion criteria
Gestational age <33 weeks or body weight <1500g.
Older than 12 hours of birth.
Neonates deemed inappropriate for cooling because of critical clinical conditions, such as severe haemorrhagic diathesis, congenital malformations, infection and cardiopulmonary failure.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osuke Iwata |
Organization
Kurume University School of Medicine
Division name
Dept of Paediatrics
Zip code
Address
67 Asahimachi, Kurume, Fukuoka, 830-0011 Japan
TEL
0942-35-3311
oiwata@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kennosuke Tsuda |
Organization
Yokohama City University Medical Center
Division name
Pediatrics
Zip code
Address
4-57 Urafune, Minami, Yokohama, Kanagawa, Japan
TEL
045-261-5656
Homepage URL
kentsuda1222@hotmail.co.jp
Sponsor or person
Institute
Kurume University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Committee on Resuscitation, Japan Society of Perinatal and Neonatal Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 14 | Day |
Last modified on
| 2019 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022621
